Description / Abstract:

Replacement:

This particular standard applies to the BASIC SAFETY and
ESSENTIAL PERFORMANCE of ELECTROCARDIOGRAPHS as defined in 201.3.63
intended by themselves or as a part of an ME SYSTEM, for the
production of ECG REPORTS for diagnostic purposes, hereinafter
referred to as ME EQUIPMENT.

c) ELECTROCARDIOGRAPHS having a display that is remote from the
PATIENT (e.g. via phone lines, networks or storage media). These ME
EQUIPMENT or ME SYSTEMS are within the scope of this particular
standard excluding transmission media.

NOTE 2 ME EQUIPMENT that provide selection between diagnostic
and monitoring functions shall meet the requirements of the
appropriate standard when configured for that function.

ME EQUIPMENT intended for use under extreme or uncontrolled
environmental conditions outside the hospital environment or
physician's office, such as in ambulances and air transport, shall
comply with this particular standard. Additional standards may
apply to ME EQUIPMENT for those environments of use.